We believe a key barrier to transforming clinical research is the lack of open, integrated, transparent technology solutions that address bottlenecks in information integration and business process management. Our viewpoint is supported by a recent Forrester Research study that identifies proprietary software as "one of the biggest barriers" to interoperability in the health IT environment, and suggests wider use of open source software to address integration challenges. I This project will build on Akaka's OpenClinica platform, the leading open source clinical research solution, to develop a broad-based open source software infrastructure that enables interoperability in heterogeneous clinical and translational research, and to develop targeted commercially-supported open source solutions from this infrastructure. It will: Integrate research data across distributed heterogeneous data sources, even data from legacy sources with poor interfaces and data documentation. Automate exchange of information with other systems in the healthcare and clinical research enterprises via semantically harmonized domain models and standardized messaging interfaces. Facilitate transition of paper-based processes to electronic systems for electronic data capture of case report forms (CRFs) and patient diaries (ePRO, or electronic Patient Reported Outcomes). Improve research management and monitoring in a Good Clinical Practice-compliant environment. The resulting solution will advance the capabilities of the clinical and translational research enterprise and empower collaborative research at Academic Health Centers (AHCs), government agencies, Contract Research Organizations (CROs), and the biopharmaceutical industry. It will increase the throughput and efficiency of clinical research, operate reliably in heterogeneous environments, and enable new types of research by bringing together disparate research tools and data.